相关申请的交叉引用Cross References to Related Applications
本申请要求在2014年2月18日提交的美国临时申请No. 61/941,053的优先权，其全部内容特此通过引用并入本文。This application claims priority to US Provisional Application No. 61/941,053, filed February 18, 2014, the entire contents of which are hereby incorporated by reference.
背景技术Background technique
仍然存在对于一种能够由通常可获得的库存材料快速且廉价地制造同时提供改进的组织聚集特性的组织收集针的需要。There remains a need for a tissue collection needle that can be manufactured quickly and inexpensively from commonly available stock materials while providing improved tissue gathering properties.
发明内容Contents of the invention
带有中空内部的组织收集针提供在小平面上带有带斜面边缘的两个相对尖端，在针行进通过生物样本时，其朝向中空内部驱动组织，其中组织能够从周围组织聚集并被切断。点和斜面有利地由能够顺应使用容易获得的中空针库存原料快速制造的最小数量的切面来形成。A tissue collection needle with a hollow interior provides two opposing tips with beveled edges on a facet that, as the needle travels through a biological sample, drive tissue toward the hollow interior where the tissue can gather from surrounding tissue and be severed. The points and bevels are advantageously formed from the minimum number of cuts that can be accommodated for rapid fabrication using readily available hollow needle stock stock.
在一方面，一种针包括管，其具有围绕轴线的中空内部和包括暴露所述中空内部的开口的端部；以及布置在所述端部上的第一尖端，其中所述第一尖端由第一对小平面形成，所述第一对小平面的形状适合于切割生物样本并从所述管的第一侧朝向所述中空内部引导所述生物样本。所述针也可以包括在所述管的周边上与所述第一尖端相对的位置处布置在所述端部上的第二尖端，其中所述第一尖端比所述第二尖端从所述管的端部沿所述轴线延伸得更远，并且所述第二尖端由第二对小平面形成，所述第二对小平面的形状适合于将由所述第一尖端切割的生物样本从与所述第一侧相对的所述管的第二侧朝向所述中空内部引导，从而在所述管行进通过所述生物样本时，在所述第一尖端和所述第二尖端之间捕获所述生物样本的一部分，并且驱动所述生物样本的所述部分进入所述中空内部中。所述针可以进一步包括形成在所述第一尖端和所述第二尖端之间的狭槽，其中所述狭槽包括尖锐边缘以在所述生物样本进入所述管的中空内部时切割所述生物样本并使其与周围组织分离。In one aspect, a needle comprises a tube having a hollow interior about an axis and an end comprising an opening exposing the hollow interior; and a first tip disposed on the end, wherein the first tip is defined by A first pair of facets are formed, the first pair of facets being shaped to cut and direct a biological sample from a first side of the tube toward the hollow interior. The needle may also include a second tip disposed on the end at a position opposite the first tip on the periphery of the tube, wherein the first tip is more spaced from the second tip than the second tip. The end of the tube extends further along the axis, and the second tip is formed by a second pair of facets shaped to separate the biological sample cut by the first tip from the A second side of the tube opposite the first side is directed toward the hollow interior such that as the tube travels through the biological sample, all a portion of the biological sample and drive the portion of the biological sample into the hollow interior. The needle may further include a slot formed between the first tip and the second tip, wherein the slot includes a sharp edge to cut the biological sample as it enters the hollow interior of the tube. biological sample and separate it from surrounding tissue.
实施方式可具有以下特征中的一个或多个。所述第一对小平面中的第一个和所述第二对小平面中的第一个可位于第一平面中。所述第一对小平面中的第二个和所述第二对小平面中的第二个可位于第二平面中。所述第一平面可具有由旋转切割工具限定的曲率。所述第二平面可具有由旋转切割工具限定的曲率。所述第一平面和所述第二平面可偏离所述管的轴线旋转大约三十度，并且相对于彼此围绕所述管的轴线旋转大约六十度。所述第一尖端和所述第二尖端可位于所述第一平面与所述第二平面相交的线上。所述狭槽可实质上垂直于连结所述第一尖端和所述第二尖端的线。所述狭槽可由对角地形成于所述管的端部中的一对平面切面形成，其中该对平面切面相交以形成所述狭槽。所述平面切面中的第一个可偏离所述管的所述轴线大约十五度。所述平面切面中的第二个可偏离所述管的轴线大约二十度。所述管可具有大约0.050英寸的外直径和大约0.038英寸的内直径。所述针也可以包括通管丝（stylet），所述通管丝的形状和大小适合于配合在所述管的所述中空内部内与所述管的内表面滑动接触。通管丝可具有尖端，所述尖端的形状与包括所述第一尖端和所述第二尖端的所述管的端部的凸壳实质上一致。Implementations can have one or more of the following features. The first of the first pair of facets and the first of the second pair of facets may lie in a first plane. The second of the first pair of facets and the second of the second pair of facets may lie in a second plane. The first plane may have a curvature defined by the rotating cutting tool. The second plane may have a curvature defined by the rotating cutting tool. The first plane and the second plane are rotatable about thirty degrees from the axis of the tube and about sixty degrees relative to each other about the axis of the tube. The first tip and the second tip may be located on a line where the first plane intersects the second plane. The slot may be substantially perpendicular to a line joining the first tip and the second tip. The slot may be formed by a pair of planar cuts formed diagonally in the end of the tube, wherein the pair of planar cuts intersect to form the slot. A first of said planar cuts may be approximately fifteen degrees offset from said axis of said tube. A second of the planar cuts may be approximately twenty degrees offset from the axis of the tube. The tube may have an outer diameter of about 0.050 inches and an inner diameter of about 0.038 inches. The needle may also include a stylet shaped and sized to fit within the hollow interior of the tube in sliding contact with an inner surface of the tube. The stylet may have a tip shaped to substantially conform to the convex shell of the end of the tube including the first tip and the second tip.
在一方面，一种用于制造针的方法包括：提供管，其具有通过中空内部的轴线和开放端部；相对于所述轴线以第一角度在所述开放端部中形成第一切面；相对于所述轴线以与所述第一角度相对的第二角度在所述开放端部中形成第二切面，使得所述第二切面与所述第一切面交汇，以从所述管的所述端部移除楔形部，从而在所述管的周边的相对侧上提供第一尖端和第二尖端。所述方法也可以包括相对于所述轴线以第三角度形成第三切面，其中所述第三切面与所述第一尖端和所述第二尖端相交。所述方法可以进一步包括相对于所述轴线以第四角度形成第四切面，其中所述第四切面围绕所述轴线旋转一定旋转角度，使得所述第三切面在所述第一尖端与所述第二尖端之间的线中与所述第四切面相交，从而在所述管的所述开放端部中在所述第一尖端和所述第二尖端上提供切割表面，并且其中所述第一尖端上的斜面指向所述轴线。In one aspect, a method for manufacturing a needle comprises: providing a tube having an axis through a hollow interior and an open end; forming a first cut plane in the open end at a first angle relative to the axis forming a second cut plane in said open end at a second angle opposite to said first angle with respect to said axis such that said second cut plane meets said first cut plane to obtain from said tube The end of the tube removes the wedge, thereby providing a first tip and a second tip on opposite sides of the circumference of the tube. The method may also include forming a third cut plane at a third angle relative to the axis, wherein the third cut plane intersects the first tip and the second tip. The method may further comprise forming a fourth cut plane at a fourth angle with respect to the axis, wherein the fourth cut plane is rotated about the axis by an angle of rotation such that the third cut plane is between the first tip and the A line between the second tips intersects the fourth cutting plane, thereby providing a cutting surface on the first tip and the second tip in the open end of the tube, and wherein the first tip A bevel on the tip points towards the axis.
实施方式可具有以下特征中的一个或多个。所述第一切面和所述第二切面可垂直于所述管的所述轴线交汇并从所述管的所述轴线偏移，从而形成不对称楔形部，并且其中所述第一尖端比所述第二尖端从所述开放端部延伸得更远。所述第一切面、所述第二切面、所述第三切面以及所述第四切面中的至少一者可用旋转切割工具形成。所述旋转切割工具可包括旋转刀片或旋转磨削工具。所述第一切面、所述第二切面、所述第三切面以及所述第四切面中的至少一者可用电火花机械切割工具形成。所述第三切面和所述第四切面之间的旋转角度可以是围绕所述轴线大约六十度。所述第一切面和所述第二切面可交汇以形成实质上垂直于所述轴线的狭槽。所述第一切面可处于偏离所述管的所述轴线大约十五度的平面中。所述第二切面可处于偏离所述管的所述轴线大约二十度的平面中。所述管可具有大约0.050英寸的外直径和大约0.038英寸的内直径。所述管可由外科医用不锈钢形成。所述方法可以进一步包括提供形状和大小适合于配合在所述管的中空内部内的通管丝、将所述通管丝放置在所述管中，以及在所述通管丝突出通过所述开放端部时，通过形成至少所述第三切面和所述第四切面使所述通管丝的尖端成形以符合所述管的所述端部的凸壳。Implementations can have one or more of the following features. The first cut plane and the second cut plane may meet perpendicular to and offset from the axis of the tube to form an asymmetric wedge, and wherein the first tip is larger than The second tip extends further from the open end. At least one of the first cut surface, the second cut surface, the third cut surface, and the fourth cut surface may be formed with a rotary cutting tool. The rotary cutting tool may comprise a rotary blade or a rotary grinding tool. At least one of the first cut surface, the second cut surface, the third cut surface, and the fourth cut surface may be formed with an EDM cutting tool. The angle of rotation between the third cut plane and the fourth cut plane may be approximately sixty degrees about the axis. The first cut plane and the second cut plane may meet to form a slot substantially perpendicular to the axis. The first cut plane may lie in a plane approximately fifteen degrees from the axis of the tube. The second cut plane may be in a plane approximately twenty degrees from the axis of the tube. The tube may have an outer diameter of about 0.050 inches and an inner diameter of about 0.038 inches. The tube may be formed from surgical grade stainless steel. The method may further comprise providing a stylet shaped and sized to fit within the hollow interior of the tube, placing the stylet in the tube, and after the stylet protrudes through the Upon opening the end, the tip of the stylet is shaped to conform to the convex hull of the end of the tube by forming at least the third cut surface and the fourth cut surface.
附图说明Description of drawings
从其如附图中所示的具体实施例的以下描述中将显而易见到本文所描述的装置、系统、套件以及方法的前述和其它目标、特征以及优点。附图不必须按比例绘制，代替地，重点放在图示本文所描述的装置、系统、套件以及方法的原理上。The foregoing and other objects, features and advantages of the devices, systems, kits and methods described herein will be apparent from the following description of specific embodiments thereof as shown in the accompanying drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the devices, systems, kits, and methods described herein.
图1是组织收集针的透视图。Figure 1 is a perspective view of a tissue collection needle.
图2是组织收集针的侧视图。Figure 2 is a side view of a tissue collection needle.
图3是组织收集针的旋转的后侧视图。Figure 3 is a rear side view of the rotation of the tissue collection needle.
图4是组织收集针的前视图。Figure 4 is a front view of a tissue collection needle.
图5是组织收集针的俯视图。Figure 5 is a top view of the tissue collection needle.
图6示出用于制造组织收集针的方法。Figure 6 shows a method for making a tissue collection needle.
具体实施方式Detailed ways
现在将参考附图更全面地描述实施例，附图中示出优选实施例。然而，上文可以以许多不同形式体现，并且不应被解释为限制于本文所阐述的图示实施例。而且，提供这些图示实施例使得本公开将向本领域技术人员传达该范围。Embodiments will now be described more fully with reference to the accompanying drawings, in which preferred embodiments are shown. However, the above may be embodied in many different forms and should not be construed as limited to the illustrated embodiments set forth herein. Rather, these illustrated embodiments are provided so that this disclosure will convey the scope to those skilled in the art.
本文所提及的所有文献特此通过引用以其全部并入本文。提及呈单数形式的物品应被理解为包括呈复数形式的物品，且反之亦然，除非以其它方式明确地陈述或从文本中清晰可见。语法连接词旨在表达结合的短语、句子、词汇等的任意和全部转折性和连接性组合，除非以其它方式明确地陈述或从上下文中清晰可见。因此，术语“或”应大体上被理解为意味着“和/或”等等。All documents mentioned herein are hereby incorporated by reference in their entirety. Reference to an item in the singular should be understood to include an item in the plural and vice versa unless expressly stated otherwise or clear from the text. Grammatical connectives are intended to express any and all transitional and connective combinations of phrases, sentences, words, etc. that are joined, unless expressly stated otherwise or clear from the context. Thus, the term "or" should generally be read to mean "and/or" and so on.
本文中值的范围的叙述不旨在是限制性的，而是单独地指代落在该范围内的任何值和所有值，除非本文中做出其它指示，并且落在该范围内的每个单个值并入说明书中，如同其在本文中被单独地叙述那样。当伴随数值或其它性质时，词汇“大约”、“近似”、“实质上”等应被解释为指示如本领域普通技术人员将理解的那样的偏差，以针对预期目的令人满意地操作。值和/或数值的范围在本文中仅作为示例提供，并且不构成对所描述的实施例的范围的限制。本文所提供的任何和所有示例或示例性语言（“例如”、“诸如”等）的使用仅旨在更好地阐明实施例并且不对实施例的范围造成限制。说明书中的语言均不应被解释为指示任何未要求保护的元件对实施例的实践而言是必须的。The recitation of ranges of values herein is not intended to be limiting, but rather refers individually to any and all values falling within that range, unless otherwise indicated herein, and each value falling within that range Individual values are incorporated into the specification as if they were individually recited herein. The words "about", "approximately", "substantially" etc. when accompanying numerical or other properties should be construed to indicate deviations as would be understood by those of ordinary skill in the art for satisfactory operation for the intended purpose. Values and/or ranges of values are provided herein as examples only, and are not intended to limit the scope of the described embodiments. The use of any and all examples, or exemplary language ("for example," "such as," etc.) provided herein is intended merely to better illuminate the embodiments and does not pose a limitation on the scope of the embodiments. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the embodiment.
在以下描述中，应理解术语（诸如“第一”、“第二”、“顶部”、“底部”、“上方”、“下方”等）是为了便利的词汇并且不解释为限制性术语。In the following description, it should be understood that terms such as "first", "second", "top", "bottom", "above", "below", etc. are words of convenience and are not to be construed as limiting terms.
本文中的实施例涉及一种带有增加的组织收集能力的新颖的针尖端几何结构，以便在活组织检查和其它组织取样程序中使用。Embodiments herein relate to a novel needle tip geometry with increased tissue collection capabilities for use in biopsies and other tissue sampling procedures.
图1是组织收集针的透视图。总体地，针100可具有带有围绕轴线106的中空内部104的管102，和包括使中空内部104暴露的开口110的端部108。Figure 1 is a perspective view of a tissue collection needle. Generally, the needle 100 may have a tube 102 with a hollow interior 104 about an axis 106 and an end 108 including an opening 110 exposing the hollow interior 104 .
第一尖端112可布置在端部108上。第一尖端112可由第一对小平面114、116形成，该第一对小平面114、116的形状适合于切割生物样本（未示出），并从管102的第一侧118朝向中空内部引导生物样本（大体上从图1中描绘的底部，其中组织被朝向轴线106向上引导）。例如，小平面112、114可以是带有大体上由用以形成平面表面的切割工具确定的形状的平面表面（诸如平坦平面表面或弯曲平面表面）。这些平面表面相交处的线可将第一尖端112形成为尖锐的点。第一尖端112也可以是略微圆化的或以其它任何合适的方式成形，以便在针100被驱动到生物样本中时刺穿生物样本中的组织等。小平面114、116的边缘可由于用以形成小平面114、116的切割或磨削过程而在管102的内侧或外侧上形成锋利的切割表面，或可额外地被磨尖或以其它方式成形或处理以改进针的有效性。The first tip 112 may be disposed on the end 108 . The first tip 112 may be formed by a first pair of facets 114, 116 shaped to cut a biological sample (not shown) and directed from the first side 118 of the tube 102 towards the hollow interior. Biological sample (generally from the bottom depicted in FIG. 1 , where tissue is directed upwards towards axis 106 ). For example, the facets 112, 114 may be planar surfaces (such as flat planar surfaces or curved planar surfaces) with a shape generally determined by the cutting tool used to form the planar surfaces. The line where these planar surfaces meet may form the first tip 112 as a sharp point. The first tip 112 may also be slightly rounded or shaped in any other suitable manner to pierce tissue or the like in a biological sample as the needle 100 is driven into the biological sample. The edges of the facets 114, 116 may form sharp cutting surfaces on the inside or outside of the tube 102 as a result of the cutting or grinding process used to form the facets 114, 116, or may additionally be sharpened or otherwise shaped. or treatment to improve needle effectiveness.
第二尖端122也可以布置在端部108上。第二尖端122可由第二对小平面124、126形成，第二对小平面124、126的形状适合于切割生物样本（未示出）并从与第一侧118相对的管102的第二侧128朝向中空内部引导生物样本（大体从图1中描绘的顶部，其中组织被朝向轴线106向下引导）。例如，小平面122、124可以是带有大体上由用以形成平面表面的切割工具所确定的平面几何构造的平面表面（诸如平坦平面表面或弯曲平面表面）。这些平面表面相交处的线可将第二尖端122形成为尖锐的点。第二尖端122也可以是略微圆化的或以其它任何合适方式成形，以便在针100被驱动到生物样本中时刺穿生物样本中的组织等，并且朝向中空内部104聚集组织。小平面124、126的边缘可由于用以形成小平面124、126的切割或磨削过程而在管102的内侧和外侧上形成锋利的切割表面，或可额外地被磨尖或以其它方式成形或处理以改进针的有效性。The second tip 122 may also be disposed on the end 108 . Second tip 122 may be formed by a second pair of facets 124, 126 that are shaped to cut a biological sample (not shown) and extend from a second side of tube 102 opposite first side 118. 128 directs the biological sample toward the hollow interior (generally from the top depicted in FIG. 1 , where tissue is directed downward toward axis 106 ). For example, the facets 122, 124 may be planar surfaces (such as flat planar surfaces or curved planar surfaces) with planar geometry generally determined by the cutting tool used to form the planar surfaces. The line where these planar surfaces meet may form the second tip 122 as a sharp point. Second tip 122 may also be slightly rounded or shaped in any other suitable manner to pierce tissue or the like in a biological sample and gather tissue toward hollow interior 104 as needle 100 is driven into the biological sample. The edges of the facets 124, 126 may form sharp cutting surfaces on the inside and outside of the tube 102 as a result of the cutting or grinding process used to form the facets 124, 126, or may additionally be sharpened or otherwise shaped. or treatment to improve needle effectiveness.
总体地，第二尖端122可在与第一尖端112相对的位置处布置在管102的周边上。第一尖端112可以比第二尖端122从端部108沿轴线106延伸得更远，使得在向前驱动针100时，第一尖端112引导第二尖端122。在这种构造的情况下，在管102行进通过生物样本时，针100能够捕获第一尖端112和第二尖端122之间的生物样本的一部分，并且驱动生物样本的该部分进入中空内部104中。小平面114、116、124、126可取向为增强这种捕获功能，且小平面114、116、124、126的边缘可同时提供切割边缘从而切断以该方式聚集的样本。Generally, the second tip 122 may be disposed on the periphery of the tube 102 at a location opposite the first tip 112 . First tip 112 may extend farther from end 108 along axis 106 than second tip 122 such that first tip 112 guides second tip 122 as needle 100 is driven forward. With this configuration, needle 100 is capable of capturing a portion of the biological sample between first tip 112 and second tip 122 and driving that portion of the biological sample into hollow interior 104 as tube 102 travels through the biological sample. . The facets 114, 116, 124, 126 may be oriented to enhance this capture function, and the edges of the facets 114, 116, 124, 126 may simultaneously provide a cutting edge to sever sample collected in this manner.
小平面114、116、124、126可以有利地以共享平面表面的成对形式制造。例如，第一对小平面中的一个114和第二对小平面中的一个124可位于第一平面（诸如，由用以同时制造这两个小平面114、124的切割工具形成的平面）中。该第一平面可具有由旋转切割工具（诸如旋转磨削工具）限定的曲率。相似地，第一对小平面中的第二个116和第二对小平面中的第二个126可位于第二平面（诸如，由用以制造这两个小平面116、126的切割工具形成的平面）中。该第二平面也可以具有由旋转切割工具（诸如旋转磨削工具）限定的曲率，该旋转切割工具可与用以形成第一平面的旋转切割工具相同，或是带有不同曲率半径的不同旋转工具。在另一方面，可使用产生平坦平面切面的工具（诸如，电火花机械（EDM）、旋转锯或带锯）来切割或形成这些平面中的一个或多个。The facets 114, 116, 124, 126 may advantageously be fabricated in pairs that share a planar surface. For example, one 114 of the first pair of facets and one 124 of the second pair of facets may lie in a first plane, such as the plane formed by the cutting tool used to simultaneously fabricate the two facets 114, 124 . The first plane may have a curvature defined by a rotating cutting tool, such as a rotating grinding tool. Similarly, the second 116 of the first pair of facets and the second 126 of the second pair of facets may lie in a second plane (such as formed by the cutting tool used to make the two facets 116, 126). plane). The second plane may also have a curvature defined by a rotating cutting tool, such as a rotating grinding tool, which may be the same as the rotating cutting tool used to form the first plane, or a different rotation with a different radius of curvature. tool. In another aspect, one or more of these planes may be cut or formed using a tool that produces flat planar cuts, such as an electric discharge machine (EDM), rotary saw, or band saw.
针100可以可选地包括通管丝（stylet）130以辅助样本收集。通管丝130可由形状适合于且带有适合于配合在管102的中空内部104内与管102的内表面滑动接触的外直径的原材料（诸如外科医用不锈钢等）的圆筒部段形成。通管丝130可通过以下方式形成：将原材料放置到延伸出开口110的管102内，同时制出多个平面切面以形成如上文描述的那样的第一尖端112和第二尖端122（而且当制出其它切面以形成如下文所描述的狭槽时不延伸通过开口110）。因此，通管丝130的端部可包括两个平面，当放置在针100的开口110中并准确地旋转取向时，所述两个平面将与由端部108的小平面114、116、124、126形成的针100上的两个平面一致。换言之，通管丝130的端部可具有形状和大小与包括第一尖端112和第二尖端122的管102的端部108的凸壳实质上一致的通管丝尖端。Needle 100 may optionally include a stylet 130 to aid in sample collection. The stylet 130 may be formed from a cylindrical section of stock material, such as surgical stainless steel, etc., shaped and having an outer diameter adapted to fit within the hollow interior 104 of the tube 102 in sliding contact with the inner surface of the tube 102 . The stylet 130 may be formed by placing raw material into the tube 102 extending out of the opening 110 while making multiple planar cuts to form the first tip 112 and the second tip 122 as described above (and when Other cuts are made to form slots as described below that do not extend through opening 110 ). Accordingly, the end of the stylet 130 may include two flats that will align with the facets 114, 116, 124 of the end 108 when placed in the opening 110 of the needle 100 and in the correct rotational orientation. The two planes on the needle 100 formed by , 126 are consistent. In other words, the end of the stylet 130 may have a stylet tip substantially conforming in shape and size to the convex shell of the end 108 of the tube 102 including the first tip 112 and the second tip 122 .
总体地，当不期望样本收集时，可将通管丝130保留在针100内侧，使得在针100行进时，通管丝130和针100的端部108的相对连续的几何构造引起组织等被围绕整个针100引导。不同地，当期望样本收集时，可将通管丝130从针100移除（或至少从开口110退出）。在这种后者构造中，第一尖端112和第二尖端122能够接合并朝向针100的中空内部104引导样本以便收集。In general, when sample collection is not desired, the stylet 130 can be retained inside the needle 100 such that as the needle 100 is advanced, the relatively continuous geometry of the stylet 130 and the end 108 of the needle 100 causes tissue, etc. Guide around the entire needle 100. Differently, the stylet 130 may be removed from the needle 100 (or at least withdrawn from the opening 110) when sample collection is desired. In this latter configuration, the first tip 112 and the second tip 122 are capable of engaging and directing the sample toward the hollow interior 104 of the needle 100 for collection.
图2是组织收集针的侧视图，其可以是针200（诸如上文所描述的针中的任意针）。总体地，第一尖端212和第二尖端222的切割和聚集功能可以通过在针内切割出狭槽240得以增强。例如，狭槽240可以利用包括沿第一平面242的第一切面和沿第二平面244的第二切面的一对平面切面形成在第一尖端212与第二尖端222之间，第一切面和第二切面两者均对角地形成于针200的管202的端部内，并且相交以形成狭槽240。平面242、244可具有相对于针200的轴线相似或等同的相对倾斜，并且可稍微偏离针200的中心中的轴线相交，以形成实质上垂直于连结第一尖端212和第二尖端222的线的狭槽240。例如，狭槽240可由一对切面形成，其中第一平面242偏离轴线大约二十度，且第二平面244沿相对方向（即，围绕针200的轴线旋转180度）偏离轴线大约十五度。将理解的是，也可以使用或替代地使用其它角度，并且对于样本收集中针200的有效操作而言，不需要围绕针200的轴线精确对称。还将理解的是，尽管可便利地在针200的尖端212、224之后形成狭槽240，但并不严格要求这种制造步骤顺序，并且狭槽240的对角楔形部可在形成尖锐的尖端和邻近的带斜面切割边缘的两个平面切面之前形成。例如，可基于以下因素选择步骤的顺序：期望形成切割边缘的顺序、与匹配的几何构造的通管丝的形成的协调，或者任何其它制造优点或便利性。2 is a side view of a tissue collection needle, which may be a needle 200 (such as any of the needles described above). Overall, the cutting and gathering functions of the first tip 212 and the second tip 222 can be enhanced by cutting a slot 240 into the needle. For example, the slot 240 may be formed between the first tip 212 and the second tip 222 using a pair of planar cuts including a first cut along the first plane 242 and a second cut along the second plane 244, the first cut Both the face and the second cut surface are formed diagonally within the end of the tube 202 of the needle 200 and intersect to form the slot 240 . The planes 242, 244 may have a similar or equivalent relative inclination with respect to the axis of the needle 200 and may intersect slightly offset from the axis in the center of the needle 200 to form a line substantially perpendicular to the line joining the first tip 212 and the second tip 222. The slot 240. For example, the slot 240 may be formed by a pair of cut planes where a first plane 242 is approximately twenty degrees off axis and a second plane 244 is approximately fifteen degrees off axis in the opposite direction (ie, rotated 180 degrees about the axis of needle 200 ). It will be appreciated that other angles may also or alternatively be used, and that exact symmetry about the axis of the needle 200 is not required for efficient operation of the needle 200 in sample collection. It will also be appreciated that while the slot 240 may conveniently be formed after the tips 212, 224 of the needle 200, this order of manufacturing steps is not strictly required and that the diagonal wedge of the slot 240 may be formed after the sharp tip. and adjacent two flat cuts with beveled cutting edges formed before. For example, the order of steps may be selected based on the order in which cutting edges are desired to be formed, coordination with the formation of stylets of matching geometry, or any other manufacturing advantage or convenience.
狭槽240可包括尖锐的边缘244以在生物样本进入针200的管的中空内部时切割生物样本并使其与周围组织分离。例如，尖锐的边缘244可被形成为用以形成第一平面240和第二平面242的切割过程的产物，或可在任何合适的后续磨尖过程中添加尖锐的边缘244。在一方面，狭槽200可形成锐利的转角，其带有不大于0.005英寸的半径，或成用用以形成第一平面240和第二平面242的切割过程能够实现的最小半径。Slot 240 may include sharp edges 244 to cut the biological sample and separate it from surrounding tissue as it enters the hollow interior of the barrel of needle 200 . For example, the sharpened edge 244 may be formed as a product of the cutting process used to form the first flat 240 and the second flat 242, or the sharpened edge 244 may be added in any suitable subsequent sharpening process. In one aspect, the slot 200 can form a sharp corner with a radius no greater than 0.005 inches, or the smallest radius achievable by the cutting process used to form the first flat 240 and the second flat 242 .
图3是组织收集针（诸如上文所描述的针中的任意针）的旋转后侧视图。如上文所述，针300具有由切入针300的端部中的一对平面切面形成的第一尖端312和第二尖端322。相对于针300的轴线306，这些平面切面360可具有任何合适角度362以便形成有用的切割点，诸如偏离管302的轴线306大约三十度。平面切面360中的每个还具有围绕轴线的旋转取向，且第一平面和第二平面可围绕管302的轴线相对于彼此旋转大约六十度以形成第一尖端312和第二尖端322。这在制造中可通过以下方式便利地实现：通过例如在偏离轴线306三十度下切割、磨削或以其它方式形成平面切面360中的第一个，并且然后在钳或其它装置件中使管302围绕轴线306旋转大约六十度，并且然后以新的旋转取向重复平面切面360和管302。3 is a rotated rear side view of a tissue collection needle, such as any of the needles described above. As noted above, the needle 300 has a first tip 312 and a second tip 322 formed by a pair of planar cuts cut into the end of the needle 300 . These planar cuts 360 may have any suitable angle 362 relative to the axis 306 of the needle 300 to form a useful cutting point, such as approximately thirty degrees from the axis 306 of the tube 302 . Each of the planar cuts 360 also has a rotational orientation about the axis, and the first and second planes may be rotated about sixty degrees relative to each other about the axis of the tube 302 to form the first tip 312 and the second tip 322 . This is conveniently accomplished in manufacture by cutting, grinding, or otherwise forming a first of the planar cut surfaces 360, for example, at thirty degrees off axis 306, and then using the Tube 302 is rotated approximately sixty degrees about axis 306 and then planar cut 360 and tube 302 are repeated in the new rotated orientation.
图4是组织收集针（诸如上文描述的针中的任意针）的前视图。用以形成本文所预想的针400的第一尖端412和第二尖端422的该对平面切面可大体上相交以形成线470，该线470延伸横穿管402的周边并且相对于针400的轴线从第一尖端412到第二尖端422对角地延伸。第一尖端412和第二尖端422可位于两个平面相交处的该线470上。针400的整体长度480不是关键的，并且可取决于预期用途，例如组织的类型、组织的位置、所需的样本的量等。在一方面，整体长度480可大约是0.299英寸。适合于可以有用地作为所收集的样本的人类组织的类型的其它长度可大约是0.3英寸、大约0.3125英寸或在大约0.29英寸和大约0.32英寸之间，或任何其它长度。此外，可使用以形成针400的管402在各种情形下（诸如，期望针400的延伸的所及范围）有用地延伸。4 is a front view of a tissue collection needle, such as any of the needles described above. The pair of planar cut surfaces to form the first tip 412 and the second tip 422 of the needle 400 contemplated herein may generally intersect to form a line 470 extending across the circumference of the tube 402 and relative to the axis of the needle 400 Extends diagonally from the first tip 412 to the second tip 422 . The first tip 412 and the second tip 422 may lie on this line 470 where the two planes intersect. The overall length 480 of needle 400 is not critical and may depend on the intended use, eg, type of tissue, location of tissue, amount of sample required, etc. In one aspect, the overall length 480 can be approximately 0.299 inches. Other lengths suitable for the type of human tissue that may be useful as collected samples may be about 0.3 inches, about 0.3125 inches, or between about 0.29 inches and about 0.32 inches, or any other length. Furthermore, the tube 402 that may be used to form the needle 400 is usefully extended in various circumstances, such as the extent to which the needle 400 is desired to extend.
图5是组织收集针（诸如上文描述的针中的任意针）的俯视图。针500可由任何合适的材料（诸如18TW gauge针原料或任何其它外科医用不锈钢管等）做成。在一方面，针500可具有大约0.038英寸的内直径502和大约0.050英寸的外直径504。5 is a top view of a tissue collection needle, such as any of the needles described above. Needle 500 may be made of any suitable material (such as 18TW gauge needle stock or any other surgical stainless steel tubing, etc.). In one aspect, the needle 500 can have an inner diameter 502 of about 0.038 inches and an outer diameter 504 of about 0.050 inches.
图6示出用于制造组织收集针的方法。总体地，本文预想到一种用于制造组织收集针的方法，其有利地使用小量切面来实现带有带斜面的切割边缘的多点组织收集针，以在针行进时朝向组织收集区域（例如，中空管的中心）驱动组织，以及带有狭槽以从生物样本捕获并切断所聚集的组织。Figure 6 shows a method for making a tissue collection needle. In general, this paper envisions a method for fabricating a tissue collection needle that advantageously uses a small number of facets to achieve a multi-point tissue collection needle with a beveled cutting edge to target the tissue collection area ( For example, the center of the hollow tube) drives tissue, and has slots to capture and sever accumulated tissue from a biological sample.
如在步骤602中所示，方法600可以提供管以制造针开始。管可以是上文描述的管中的任意管，诸如18TW gauge针原料或外科医用不锈钢的任何其它合适尺寸的中空管等，并且将大体上具有中空内部和其中能够形成针尖端的开放端部。As shown in step 602, method 600 may begin by providing a tube to fabricate a needle. The tube may be any of the tubes described above, such as 18TW gauge needle stock or any other suitable sized hollow tube of surgical stainless steel, etc., and will generally have a hollow interior and an open end into which a needle tip can be formed .
如在步骤604中所示，方法600可包括相对于轴线以第一角度（诸如偏离管的轴线大约十五到二十度）在开放端部中形成第一切面。该步骤和下文描述的各种切割步骤可利用任何合适的切割机器（包括但不限于电火花机械（EDM）切割工具、旋转切割工具（诸如旋转磨削工具或旋转刀片）、带锯等）来执行。As shown in step 604 , method 600 may include forming a first cut plane in the open end at a first angle relative to the axis, such as approximately fifteen to twenty degrees from the axis of the tube. This step and the various cutting steps described below can be performed using any suitable cutting machine, including but not limited to electrical discharge mechanical (EDM) cutting tools, rotary cutting tools (such as rotary grinding tools or rotary blades), band saws, etc. implement.
如步骤606中所示，方法600可包括在开放端部中并且相对于轴线以与第一角度相对的第二角度（诸如大约二十到二十五度）形成第二切面，使得第二切面与第一切面交汇以从管的端部移除楔形部，从而在管的周边的相对侧上提供第一尖端和第二尖端。第一切面和第二切面可垂直于管的轴线交汇并且从管的轴线偏移，以形成不对称楔形部，并且其中第一尖端比第二尖端从管的开放端部延伸得更远。切面可同时形成实质上垂直于针的管的轴线的狭槽（在楔形部的顶点处）。As shown in step 606, method 600 may include forming a second cut plane in the open end and at a second angle relative to the axis, such as approximately twenty to twenty-five degrees, relative to the axis, such that the second cut plane Intersecting the first cut plane removes the wedge from the end of the tube to provide a first tip and a second tip on opposite sides of the perimeter of the tube. The first and second cut planes may meet perpendicular to and offset from the axis of the tube to form an asymmetric wedge and wherein the first tip extends further from the open end of the tube than the second tip. The cut surfaces may at the same time form a slot (at the apex of the wedge) substantially perpendicular to the axis of the barrel of the needle.
如步骤608中所示，方法600可包括形成通管丝。这可例如包括提供形状和大小适合于配合在管的中空内部内的通管丝、将通管丝放置在管中，并且然后使通管丝成形以与管的端部的凸壳一致，或以其它方式匹配针的形状。可以在下文的步骤中形成针的尖锐点的同时有利地执行该步骤，例如，通过在通管丝突出通过管的开放端部时形成步骤610-612的切面。在形成该对平面切面以形成针的两个尖锐点的同时，通管丝的端部可同时形成为带有匹配的外部形状。在步骤610和612之后执行步骤604和608的情况下，可移除通管丝以便避免以与针相同的方式将通管丝开槽。在另一方面，通管丝的形状和大小仅适合于配合在管的中空内部内，而且以其它方式其形状不与管的端部的凸壳一致或以其它方式匹配管的端部的形状。As shown in step 608, method 600 may include forming a stylet. This may, for example, include providing a stylet shaped and sized to fit within the hollow interior of the tube, placing the stylet in the tube, and then shaping the stylet to conform to the convex shell of the end of the tube, or Match the needle shape in other ways. This step may advantageously be performed at the same time as forming the sharp point of the needle in subsequent steps, eg, by forming the cut surfaces of steps 610-612 as the stylet protrudes through the open end of the tube. At the same time as the pair of planar cuts are formed to form the two sharp points of the needle, the end of the stylet can be simultaneously formed with a matching outer shape. Where steps 604 and 608 are performed after steps 610 and 612, the stylet may be removed to avoid slotting the stylet in the same manner as the needle. On the other hand, the stylet is only shaped and sized to fit within the hollow interior of the tube, and is otherwise not shaped to conform to or otherwise match the shape of the tube's end. .
如步骤610中所示，方法600可包括相对于轴线以第三角度形成第三切面，该第三切面与第一尖端和第二尖端相交。相对于轴线的第三角度可大约为三十度。As shown in step 610, method 600 may include forming a third cut plane at a third angle relative to the axis, the third cut plane intersecting the first tip and the second tip. The third angle with respect to the axis may be approximately thirty degrees.
如步骤612中所示，方法600可包括相对于轴线以第四角度形成第四切面，该第四切面围绕轴线旋转一定旋转角度，使得第三切面在第一尖端和第二尖端之间的线中与第四切面相交，由此在管的开放端部中在第一尖端和第二尖端上提供切割表面，并且其中第一尖端上的斜面指向轴线。相对于轴线的第四角度可大约为三十度，和/或可以等于第三角度。例如，第三切面和第四切面之间的旋转角度可以是围绕管的轴线大约六十度，或在大约五十度和七十度之间，或适合于在针的端部上根据需要形成尖锐点和切割表面的任何其它旋转角度。As shown in step 612, method 600 may include forming a fourth cut plane at a fourth angle relative to the axis, the fourth cut plane rotated about the axis by an angle of rotation such that the third cut plane is on the line between the first tip and the second tip The middle intersects the fourth cutting plane, thereby providing cutting surfaces on the first and second tips in the open end of the tube, and wherein the bevel on the first tip points towards the axis. The fourth angle with respect to the axis may be approximately thirty degrees, and/or may be equal to the third angle. For example, the angle of rotation between the third and fourth cut planes may be about sixty degrees around the axis of the tube, or between about fifty and seventy degrees, or be adapted to be formed as desired on the end of the needle. Sharp points and any other angle of rotation of the cutting surface.
虽然下文列举了步骤的具体顺序，但将理解的是，本文所预想的切面可以以任何有用或便利的顺序执行，只要其组合以提供本文所预想的期望尖端几何构造。因此，例如，可首先形成在步骤610-612中所描述的切面，并且然后可用切入管的端部内的对角切面形成楔形部和狭槽。因此，描述了一种制造技术，其中能够使用切入外科医用不锈钢的圆筒形库存原料内的小量切面制造组织收集针。切面的位置和取向可进一步减少对于精整步骤的需要，诸如通过在用以形成针的多个平面切割操作期间在期望位置处放置斜面和尖锐边缘来修边（edging）。Although a specific order of steps is recited below, it will be understood that the facets contemplated herein may be performed in any useful or convenient order so long as they are combined to provide the desired tip geometry envisioned herein. Thus, for example, the cuts described in steps 610-612 may be formed first, and then the wedges and slots may be formed with diagonal cuts cut into the end of the tube. Thus, a fabrication technique is described in which tissue collection needles can be fabricated using small facets cut into a cylindrical stock stock of surgical stainless steel. The location and orientation of the facets can further reduce the need for finishing steps, such as edging by placing bevels and sharp edges at desired locations during the multiple planar cutting operations to form the needle.
将认识到的是，上文描述的装置、系统、套件以及方法以示例方式而非以限制方式提出。在没有不同的明确指示的情况下，可以在不偏离本公开的范围的情况下对所公开的步骤进行修改、补充、忽略和/或重新排序。本领域普通技术人员显而易见到多种变型、添加、忽略和其它改型。此外，在以上描述和附图中方法步骤的顺序或呈现不旨在要求执行所陈述的步骤的这种顺序，除非明确需要特定顺序或以其它方式从上下文清晰可见特定顺序。It will be appreciated that the devices, systems, kits and methods described above are presented by way of example and not limitation. In the absence of a different express indication, the disclosed steps may be modified, supplemented, omitted and/or reordered without departing from the scope of the present disclosure. Numerous variations, additions, omissions, and other modifications will be apparent to those of ordinary skill in the art. Furthermore, the order or presentation of method steps in the above description and drawings is not intended to require performance of the recited steps, unless a particular order is explicitly required or otherwise clear from the context.
本文所描述的实施方式的方法步骤旨在包括引起执行这种方法步骤、与以下权利要求的可专利性一致的任何合适方法，除非明确地提供了不同的意义或以其它方式从上下文清晰可见。因此，例如执行步骤X包括引起另一方、计算机源或制造装置或系统执行步骤X的任何合适方法。相似地，执行步骤X、Y和Z可包括引导或控制其它个体或源的任何组合以执行步骤X、Y和Z从而获得这种步骤的益处的任何方法。因此，本文所描述的实施方式的方法步骤旨在包括引起一个或多个其它方或实体执行步骤、与以下权利要求的可专利性一致的任何合适方法，除非明确提供了不同的意义或以其它方式从上下文清晰可见。这种方或实体不需要在任何其它方或实体的引导或控制下，并且不需要位于具体管辖内。Method steps of the embodiments described herein are intended to include any suitable method of causing performance of such method steps, consistent with the patentability of the following claims, unless a different meaning is explicitly provided or otherwise clear from the context. Thus, for example, performing step X includes any suitable method of causing another party, a computer source, or a manufacturing apparatus or system to perform step X. Similarly, performing steps X, Y, and Z may include any method of directing or controlling other individuals or any combination of sources to perform steps X, Y, and Z to obtain the benefit of such steps. Accordingly, method steps of the embodiments described herein are intended to include any suitable method of causing one or more other parties or entities to perform the steps, consistent with the patentability of the following claims, unless a different meaning is explicitly provided or otherwise indicated. The way is clear from the context. Such parties or entities need not be under the direction or control of any other parties or entities, and need not be located in a particular jurisdiction.
还应当认识到的是，以示例方式提供上述方法。在没有不同的明确指示的情况下，在不偏离本公开的范围的情况下可对所公开的步骤进行修改、补充、忽略和/或重新排序。It should also be appreciated that the methods described above are provided by way of example. In the absence of a different express indication, the disclosed steps may be modified, supplemented, omitted and/or reordered without departing from the scope of the present disclosure.
将认识到的是，上文描述的方法和系统以示例方式而非以限制方式提出。本领域普通技术人员将显而易见到多种变型、添加、忽略以及其它改型。此外，在以上描述和附图中方法步骤的顺序或呈现不旨在要求执行所陈述的步骤的这种顺序，除非明确需要特定顺序或以其它方式从上下文清晰可见特定顺序。因此，虽然已经示出并描述了具体实施例，但本领域普通技术人员将显而易见到，在不偏离本公开的精神和范围的情况下可以在形式和细节中做出各种改变或修改，且旨在形成如由将以法律可允许的最广泛意义解释的以下权利要求所限定的本发明的一部分。It will be appreciated that the methods and systems described above are presented by way of example and not limitation. Variations, additions, omissions, and other modifications will be apparent to those of ordinary skill in the art. Furthermore, the order or presentation of method steps in the above description and drawings is not intended to require performance of the recited steps, unless a particular order is explicitly required or otherwise clear from the context. Therefore, while particular embodiments have been shown and described, it will be apparent to those of ordinary skill in the art that various changes or modifications in form and details may be made without departing from the spirit and scope of the disclosure, and that It is intended to form part of this invention as defined by the following claims to be construed in the broadest sense permitted by law.
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| US201461941053P | 2014-02-18 | 2014-02-18 | |
| US61/941053 | 2014-02-18 | ||
| PCT/US2015/016353WO2015126926A1 (en) | 2014-02-18 | 2015-02-18 | Tissue collection needle |
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| CN106456139A CN106456139A (en) | 2017-02-22 |
| CN106456139Btrue CN106456139B (en) | 2019-10-22 |
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